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FDA 510(k)

MiCor A100 Wearable ECG Recorder

K-Number: K162665 · 2018-01-26

ApplicantMitac International Corp.
Decision Date2018-01-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MiCor A100 Wearable ECG Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Mitac International Corp.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K162665. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiCor A100 Wearable ECG Recorder?

MiCor A100 Wearable ECG Recorder is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Mitac International Corp.. The 510(k) number is K162665.

When did MiCor A100 Wearable ECG Recorder receive FDA 510(k) clearance?

MiCor A100 Wearable ECG Recorder received FDA 510(k) clearance on 2018-01-26, under 510(k) number K162665.

Who is the listed applicant for MiCor A100 Wearable ECG Recorder?

The FDA 510(k) record lists Mitac International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiCor A100 Wearable ECG Recorder?

The FDA product code for MiCor A100 Wearable ECG Recorder is DPS.

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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